Clark J. Kashmaier
                                                                 Part 11

The FDA issued "regulations that provide criteria for acceptance by FDA, under certain
circumstances, of electronic records, electronic signatures, and handwritten signatures
executed to electronic records as equivalent to paper records and handwritten signatures
executed on paper." (page 13420 of the
Federal Register/Volume 62, No. 54/Thursday, March
20, 1997/Rules and Regulations)

While the actual regulations are reasonably short, the issuance of these regulations has
caused significant action and concern by those who fall under the jurisdiction of FDA

In 2003, a
Guidance for Industry Part 11, Electronic Records; Electronic Signatures -- Scope
and Application
was issued by the FDA, in which (on lines 178-181) it states: "Records that
are required to be maintained under predicate rule requirements and that are maintained
in electronic format
in place of paper format [fall under Part 11].  On the other hand, records
(and any associated signatures) that are not required to be retained under predicate rules,
but are nonetheless maintained in electronic format, are not part 11 records."

Link to FDA website concerning Part 11

Link to Part 11